Cleared Traditional

Bioflux Software II (K201040) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201040 · Biotricity · Cardiovascular device
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Jul 2020
Decision
119d
Days
Class 2
Risk

K201040 is an FDA 510(k) clearance for the Bioflux Software II. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Biotricity (Redwood City, US). The FDA issued a Cleared decision on July 29, 2020 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotricity devices

Submission Details

510(k) Number K201040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2020
Decision Date July 29, 2020
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSH Recorder, Magnetic Tape, Medical

All 34
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K201040.
Carnation Ambulatory Monitor (CAM)
K210036 · Bardy Diagnostics, Inc. · Feb 2021
M5 Recorder
K202456 · Global Instrumentation, LLC · Dec 2020
Strados Remote Electronic Stethoscope Platform (RESP)
K201077 · Strados Labs · Dec 2020
Carnation Ambulatory Monitor
K200870 · Bardy Diagnostics, Inc. · May 2020
Carnation Ambulatory Monitor
K192556 · Bardy Diagnostics, Inc. · Oct 2019
Carnation Ambulatory Monitor
K191471 · Bardy Diagnostics, Inc. · Aug 2019